Chromatography System Suitability Checklist (USP <621>)

System Suitability Parameters

Define required performance criteria.

• Are system suitability acceptance criteria defined in the approved method for resolution, tailing factor, and theoretical plates? *
• Is injection repeatability (typically %RSD of replicate injections of a reference standard) specified and met? *
• Is resolution between the analyte and the closest eluting peak defined where relevant? *
• Record the required maximum %RSD for replicate standard injections.

Execution and Bracketing

• Is system suitability verified before sample analysis and, where required, bracketed throughout the run? *
• Are check standards or continuing calibration verification injections evaluated during long sequences? *
• Is the sequence terminated or invalidated if system suitability fails mid-run? *

Instrument Qualification and Data Integrity

• Is the chromatograph qualified (IQ/OQ/PQ) and included in the calibration program? *
• Are the CDS audit trails, access controls, and processing methods controlled to protect data integrity? *
• Is unauthorized reprocessing or integration parameter manipulation prevented and reviewed? *

Documentation and Review

• Are system suitability results documented and reviewed as part of the analytical data package? *
• Are system suitability failures investigated and handled through the laboratory investigation procedure? *